How To Process A Product Registration With NAFDAC
Getting a Food Or Drug Product Registered With Nigeria's Regulator

If the business you've chosen to go into involves the manufacture or
importation of goods that fall within the description of food or drug,
then be sure that you cannot legitimately carry on such trade without the
appropriate registration of the product(s) by the National Agency for Food
And Drug Administration And Control, NAFDAC. Anybody who has lived in
Nigeria or monitored the goings-on here in recent years will definitely
know that NAFDAC is one government agency that has shown full commitment
to executing its mandate without fear or favour. NAFDAC is empowered by
the relevant laws to ensure that no processed food shall be manufactured
in, imported into, exported from, or advertised, sold or distributed in
Nigeria, without NAFDAC's approval. To do so will be in breach of the law
and NAFDAC has shown it has no sympathy for such offenders. The prescribed
penalties are stiff, including forfeiture of the goods. As NAFDAC has
continually demonstrated, applying the full weight of the law is not an
option it shies away from. If you are serious about the business you
propose to engage in, the sensible way is to fully comply with the
regulatory requirements.Stringent Process
Because the product registration process of NAFDAC is stringent, persons
who require to go through it often view the process as very tasking and
may complain of frustration. The major reason is lack of working
information on what is required. This could lead to wasted time and
energy, as the unprepared applicant goes back and forth. That is why we
are are providing this guide which outlines the key requirements to enable
you understand the process and go through it with minimal anxiety.

Registration Categories And General Requirements
Currently, NAFDAC registers products in two categories: drugs and food.
Drugs include medical devices, vaccines, chemicals and pesticides,
veterinary products, nutriceuticals and supplements, herbal preparations
and cosmetics. Products may be manufactured locally or imported. However,
an application for registration can only be initiated by the Nigerian
manufacturer, for a locally manufactured food or drug product. In the case
of a product manufactured outside Nigeria , application must be by a
Nigerian representative of the foreign manufacturer and this must be a
registered company or an individual. In effect, the applicant must be
based in Nigeria and is expected to possess the capacity to control the
circulation of the product. The representative of a foreign manufacturer
must however have a duly executed Power of Attorney from the manufacturer
(signed by company MD, GM, Chairman or President) appointing and
authorizing him/it to act in that capacity and specifying the name(s) of
the product(s).
Two-Stage Registration Process
Though the specific documentations vary for different drugs and food
categories, the general procedure is similar and, broadly, is a two-stage
process:
1. Application for approval to bring in samples - not applicable if
locally manufactured
2. Application for full registration of product - applies whether locally
manufactured or imported
Requirements - Stage one (Procurement of samples)
The registration process will require samples of the product. NAFDAC
therefore grants special authorization to import such samples. Simply
apply to NAFDAC for a written authorization to import samples. Also ensure
that other documents required for clearing and taking delivery of samples
are obtained, particularly Certificate of Analysis issued by the
manufacturer and Certificate of Manufacture and Free Sale issued by the
appropriate regulatory authority in the country of origin. Samples must
also conform to stipulated product labeling regulations.
Requirements - Stage two (Application for full registration of product)
This starts with the procurement of an application form for each product -
NAFDAC approval is granted for each specific product. This simply means
that two products from the same source will still require different
approvals and numbers. In fact, two different packages of the same
products are processed as different products. The application form is also
available at NAFDAC's offices or online at NAFDAC's website. The completed
form is to be submitted to the registration division of the agency. Key Requirements
The key requirements are as follows:
(a) DRUGS
1. Application is on single product basis
2. Written application stating name of manufacturer and name (and brand,
if applicable) of product.
3. Completed NAFDAC application form (Form D-REG/001)
4. Certificate of Incorporation with the Corporate Affairs Commission, if
a company
5. Five (5) copies of the product dossier
6. Three (3) packs of the products samples
7. Notarised original copy of the duly executed Power of Attorney from the
product manufacturer (imported product)
8. Certificate of Manufacture issued by the competent health or regulatory
authority in country of origin and authenticated by the Nigerian Mission
in that country (if foreign import). Where there is no Nigerian mission,
The British High Commission or an ECOWAS country Mission will
authenticate.
9. If contract-manufactured, Contract Manufacturing Agreement, properly
executed and notarized by a Notary Public in the country of manufacture.
10. Current World Health Organisation Good Manufacturing Practice
Certificate for the manufacturer, authenticated by the Nigerian Mission.
11. Certificate of Pharmaceutical Products (COPP) duly issued and
authenticated
12. Current Superintendent Pharmacists license to practice issued by the
Pharmaceutical Council of Nigeria
13. Premises Registration License from Pharmacists Council of Nigeria
(PCN)
14. Certificate of Registration of brand name with trademark registry in
the Ministry of Commerce here in Nigeria
15. Letter of invitation from manufacturer to inspect factory abroad,
stating full name and location of plant.
16. The applicable fee payable only if documents are confirmed to be
satisfactory.
Nutriceuticals, medical devices and other regulated drug products have
similar requirements, with minor variations. Specific details can be
obtained from NAFDAC.
Other Important Requirements
Further guidelines on registration and additional requirements on product
labeling are provided in the document NAFDAC - Other Important guidelines
which you can download here. It's in PDF format.
(b)Foods: Though the requirements are generally similar, the second part
of this guide will deal with the specific requirements on food products.

FREQUENTLY ASK
QUESTIONSHow long is the registration process?
Three months if all requirements are met as and when due.

How do I begin the process of registration?
You begin with the purchase of the relevant registration application form
from the NAFDAC office closest to you and pick up the applicable
guidelines.

Where is the NAFDAC registration Office?
In Lagos, with the following addresses.

Whom do I call to report a complaint?
Call the Director (Registration and Regulatory Affairs) on 01-4748627, 01-
4772452

What is NAFDAC?s website and e-mail address?
Website: www.nafdac.gov.ng

E-mail: nafdac@nafdac.gov.ng This e-mail address is being protected from
spambots. You need JavaScript enabled to view it

HOW LONG WILL IT TAKE TO REGISTER MY FOOD PRODUCT?
.The registration of food products takes maximum of three(3) months
provided all documents and other requirements as stated in the food
registration guidelines are found to be satisfactory

IS THERE ANY CONCESSION IN REGISTRATION
TARIFF FOR VARIANTS OF IMPORTED FOOD PRODUCTS?
.YES, registration of food variants e.g. flavour, colour, e.t.c. have
concessionary tariff charges

HOW LONG WILL IT TAKE FOR MY PRODUCT
REGISTRATION CERTIFICATE TO BE READY?
Product registration certificates takes a maximum of six(6) months after
the date of approval to be ready.
CAN I DO TEST MARKETING OF MY PRODUCT BEFORE REGISTRATION?NO, TEST MARKETING OF FOOD PRODUCTS ARE NOT PERMITTED.
WHAT IS THE AGENCY DOING ABOUT THE LITERING OF THE ENVIRONMENT WITH EMPTY
SACHET PACKAGING?THE AGENCY ENSURES THAT THE SACHET PACKAGING BEARS THE LOGO &
INSCRIPTION ?DISPOSE PROPERLY: AND IT IS THE RESPONSIBILITY OF THE
MINISTRY OF ENVIRONMENT AT STATE AND LOCAL GOVERNMENT LEVEL TO ENSURE
PROPER WASTE DISPOSAL.

CAN PEOPLE NOT JUST PUT NAFDAC NUMBER
THAT DOES NOT EXIST ON THEIR OWN?Yes they do. But they are fake numbers. And they also claim they are
going to secure NAFDAC Registration Number very soon. But this is not
true.
HOW DO I KNOW THE GENUINE NAFDAC NO.?Cross check from NAFDAC website, NAFDAC green pages and from NAFDAC
offices in all the states of the Federation.

WHERE CAN I FIND THE LIST OF REGISTERED PRODUCTS?Gazzette, NAFDAC green pages and NAFDAC website, also NAFDAC offices
in Nigeria.

WHERE DO I REPORT ANY NEFARIOUS ACTIVITY WHEN PEOPLE ARE TRYING TO FAKE
NAFDAC REGULATED PRODUCT?Report to any NAFDAC office and Enforcement Directorate in Lagos. Call
NAFDAC hotlines.

CAN I REGISTER MY PRODUCT MYSELF WITHOUT KNOWING ANYBODY IN NAFDAC OR
GOING THROUGH AN AGENT?
Yes.

HOW DO I KNOW THAT THE NAME I WANT TO USE FOR REGISTRATION OF MY PRODUCT
WILL BE ACCEPTED BY NAFDAC?
Write formally to NAFDAC for clearance of Name which can hold for 2 weeks
only.

WHEN IS THE PRODUCT LIKELY TO COME OUT OF THE LABORATORY?
6-8 weeks

WHY CAN'T OUR PRODUCT WHICH IS AN INTERNATIONAL PRODUCT BE ACCEPTED AS
SOLD ALL OVER THE WORLD.
Because products must comply with the labeling regulations developed to
meet the needs of Nigeria.

HOW AND WHERE ARE CLINICAL TRIALS CONDUCTED?
Clinical trials are conducted in accordance with good clinical practice (GCP)
and are conducted in research institutions.
WHAT ARE THE REQUIREMENTS TO CONDUCT CLINICAL TRIALS IN NIGERIA?
The requirements for clinical trials can be obtained from our website:
www.nafdacnigeria.gov.ng.

ARE CLINICAL TRIALS DIRECTLY SUPERVISED BY NAFDAC?
Yes.

DO FOREIGN DRUGS GET SUBJECTED TO CLINICAL TRIALS BEFORE THEY ARE ALLOWED
FOR USE IN THE COUNTRY?
Yes. Particularly if the drug does not have adequate and well documented
use in black population or it has some race specific properties or its
efficacy, safety and usefulness needs to be proven in our population.

DO NAFDAC CHOOSE INVESTIGATORS TO CONDUCT CLINICAL TRIALS?
No. Sponsors and applicants are responsible for the choice of their trial
investigators.
HOW MANY STUDY SITES ARE CLINICAL TRIALS ARE SUPPOSED TO BE CONDUCTED?
At least two centers.

HOW LONG DOES IT TAKE TO CONDUCT CLINICAL TRIALS?
It depends on t a number of factors, some of which are:

? The design of the trial.

? The nature of the investigational product.

? The investigational product.

? The rate of recruitment of trial participants, etc.

HOW MANY PEOPLE ARE SUPPOSED TO PARTICIPATE IN CLINICAL TRIALS?The number of participants to be involved in a study depends on the
phase of the study (I, II, III or IV) and the trial design.

HOW MUCH DOES IT TAKE TO CONDUCT CLINICAL TRIAL IN NIGERIA?The applicant need to pay NAFDAC N200, 000.00 plus 5% VAT for imported
products and N50, 000.00 plus 5%VAT for local and herbal products. Other
monetary expenses related to the conduct of the trial are handled between
the sponsors and the investigators.

HOW MANY DRUGS ARE CURRENTLY UNDERGOING CLINICAL TRIALS NOW?Five products.

LIST OF BANNED FOOD COLOURS AND / OR ADDITIVES.
This is in accordance with Codex, EU, and FDA list of Banned Colours and /
or food additives. This is usually downloaded On www.codexalimentarius.net,
www.fda.gov , and www.eu.net .

CODEX LIST OF FOOD CONTAMINANTS AND MAXIMUM LIMIT IN DIFFERENT CATEGORIES
OF FOODSThis is in accordance with Codex, EU, and USFDA position on maximum
limit of contaminants in foods. However, in some cases it depends on
country?s position as some external factors can contribute to high values
of contaminants in foods. These values can be downloaded on the websites
given above.